ProMIS Neurosciences offers comments on recent FDA Advisory Committee meeting on aducanumab for the treatment of Alzheimer’s disease

FDA Office of Neuroscience argues for approval; non-binding recommendation from the Peripheral and Central Nervous System Drugs Advisory Committee is negative

TORONTO and CAMBRIDGE, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today commented on the November 6^th FDA Peripheral and Central Nervous System Drugs Advisory Committee meeting and its review of Biogen’s Biologics License Application (BLA) for aducanumab for the treatment of Alzheimer’s disease.

The key BLA components reviewed at the advisory committee meeting consisted of three clinical trials: two pivotal phase 3 trials of similar design (Study 301, 302) and one phase 1b trial (Study 103). Both Biogen and FDA acknowledged Study 301 (ENGAGE) was negative and could not contribute to the evidence for aducanumab’s effectiveness. Demonstration of effectiveness for licensing generally requires two adequate and well-controlled clinical trials that are positive. However, under certain circumstances and consistent with the 1997 FDA Modernization Act, FDA can conclude that one adequate and well-controlled clinical investigation plus confirmatory evidence is sufficient to establish effectiveness. Whether Study 302 (EMERGE) provided adequate evidence as a single study – a position strongly expressed by the FDA Office of Neuroscience – represented the key issue debated by the Advisory Committee.

Dr. Billy Dunn, Director of the Office of Neuroscience, who convened the Advisory Committee and ultimately has the authority to approve the BLA, gave the FDA presentation; he summarized the Study 302 results, stating they were “compelling”, “exceptionally persuasive”, and represented a “homerun”. However, the written review by Dr. Tristan Massie, Office of Biostatistics, embedded in the FDA briefing documents for the Advisory Committee, addressed some Study 302 inconsistencies and argued against a conclusion of substantial evidence because of the conflicting results of the two phase 3 studies.   FDA and Biogen conducted a number of subgroup analyses to explore why Study 301 and Study 302 were divergent in their results, but none of them provided a definitive answer and the committee members decided it was not possible to conclude aducanumab was effective for the treatment of Alzheimer’s disease.